Study on Sedation During Transcatheter Aortic Valve Replacement in Patients with Aortic Stenosis Using Remifentanil, Dexmedetomidine, and Propofol

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What is this study about?

This clinical trial is focused on studying the effects of different medications used for sedation during a procedure called Transcatheter Aortic Valve Replacement (TAVR). TAVR is a treatment for patients with aortic stenosis, a condition where the heart’s aortic valve becomes narrowed, affecting blood flow. The medications being studied include Remifentanil, Dexmedetomidine, Propofol, and Ketamine. These medications are used to help patients relax and feel comfortable during the procedure.

The purpose of the study is to determine if there are differences in the occurrence of certain conditions during and after the procedure, such as respiratory acidosis and emergence delirium. Respiratory acidosis is a condition where there is too much carbon dioxide in the blood, and emergence delirium is a state of confusion that can occur after waking up from sedation. The study will compare how often these conditions occur with each medication.

Participants in the study will receive one of the medications during their TAVR procedure. The study will monitor their condition during the procedure and for 24 hours afterward to check for any signs of respiratory acidosis or emergence delirium. The study aims to provide valuable information on the safety and effectiveness of these sedation medications during TAVR procedures.

1 joining the study

Upon joining the study, the patient will undergo a process to confirm eligibility. This includes verifying age between 18 and 95 years and confirming the patient’s agreement to participate by signing an informed consent form.

2 preparation for TAVR procedure

The patient will be prepared for the Transcatheter Aortic Valve Replacement (TAVR) procedure. This involves ensuring the patient is ready for sedation and the procedure itself.

3 sedation administration

During the procedure, the patient will receive sedation through infusion. The medications used include remifentanil, propofol, and ketamine hydrochloride. These are administered as solutions for injection or infusion to maintain the desired level of sedation.

4 monitoring during procedure

Throughout the procedure, the patient’s vital signs and sedation levels will be closely monitored. The goal is to achieve a specific sedation target and ensure the patient’s safety.

5 post-procedure observation

After the procedure, the patient will be observed for any immediate effects of the sedation. This includes monitoring for respiratory acidosis and emergence delirium within the first 24 hours.

6 assessment of sedation effectiveness

The effectiveness of the sedation will be assessed by measuring the time taken to reach the desired sedation level and the time to meet discharge criteria from the operating room.

7 evaluation of adverse events

The study will evaluate any adverse events that occur during and after the procedure. This includes respiratory and hemodynamic events during the procedure, as well as cognitive changes post-operation.

8 follow-up and conclusion

The patient’s recovery and any long-term effects will be monitored until the conclusion of the study, which is estimated to end by July 1, 2026.

Who Can Join the Study?

Patients who are having a procedure called Transcatheter Aortic Valve Replacement (TAVR). This is a treatment for a heart condition known as aortic stenosis, where the valve in the heart becomes narrow.
Patients must be between the ages of 18 and 95 years old.
Patients must agree to take part in the study and sign a document called an informed consent form, which explains the study and confirms their willingness to participate.

Who Cannot Join the Study?

Patients who have not undergone a procedure called transcatheter aortic valve replacement for a condition known as aortic stenosis cannot participate. This procedure involves replacing a heart valve without open-heart surgery.
Individuals who are not within the specified age range for the study are excluded. The study is looking for participants in certain age groups.
Both males and females are eligible, but if someone does not identify as either, they may not be able to participate.
People who are considered part of a vulnerable population are not included. This term refers to groups who might need special protection, like children or those unable to give consent.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Azienda Socio Sanitaria Territoriale Ovest Milanese	Legnano	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.07.2024

Trial locations

Investigated drugs:

Propofol is a medication used to help patients relax or sleep during medical procedures. In this trial, it is used to provide sedation to patients undergoing Transcatheter Aortic Valve Replacement (TAVR). The goal is to see if it affects the patient’s breathing or causes confusion after the procedure.

Dexmedetomidine is another sedative used in this trial. It helps to calm patients and can also provide pain relief. The study aims to compare its effects on breathing and mental clarity after the TAVR procedure with those of other sedatives.

Midazolam is a medication that helps patients feel relaxed or sleepy before and during medical procedures. In this trial, it is used to see how it affects breathing and mental state after the TAVR procedure compared to other sedatives.

Aortic Stenosis – Aortic stenosis is a condition where the aortic valve in the heart becomes narrowed, restricting blood flow from the heart to the rest of the body. This narrowing can lead to increased pressure within the heart, causing the heart muscle to thicken and potentially weaken over time. As the condition progresses, individuals may experience symptoms such as chest pain, fatigue, shortness of breath, and fainting, especially during physical activity. The severity of symptoms often correlates with the degree of valve narrowing. Over time, the heart’s ability to pump blood effectively may diminish, leading to further complications.

Trial ID:

2024-511018-18-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Sedation During Transcatheter Aortic Valve Replacement in Patients with Aortic Stenosis Using Remifentanil, Dexmedetomidine, and Propofol

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?